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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Powered
510(k) Number K992628
Device Name FIRSTCLASS POWER TILT AND RECLINE SEAT SYSTEM, MODEL S400
Applicant
Teftec Corp.
6929 Old Spring Branch Rd.
Spring Branch,  TX  78070 -5104
Applicant Contact THOMAS E FINCH
Correspondent
Teftec Corp.
6929 Old Spring Branch Rd.
Spring Branch,  TX  78070 -5104
Correspondent Contact THOMAS E FINCH
Regulation Number890.3860
Classification Product Code
ITI  
Date Received08/05/1999
Decision Date 10/25/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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